DOJ’S CASE AGAINST CVS AND AGAINST THE ENTIRE PRACTICE OF PHARMACY
NORMAN J CLEMENT RPH., DDS, NORMAN L. CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., INC.T. SPIRIT OF REV. IN THE SPIRIT OF WALTER R. CLEMENT BS., MS, MBA. HARVEY JENKINS MD, PH.D., IN THE SPIRIT OF C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., EVELYN J. CLEMENT, WALTER F. WRENN III., MD., JULIE KILLINGSWORTH, RENEE BLARE, RPH, DR. TERENCE SASAKI, MD LESLY POMPY MD., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., RICHARD KAUL, MD., IN THE SPIRIT OF LEROY BAYLOR, JAY K. JOSHI MD., MBA,AISHA GARDNER, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
HOW DOJ-DEA SUIT AGAINST CVS IS Mother of All Money Grabs
INTRODUCTION
For more than a decade, the US and international public has been hearing that prescription opioid pain relievers are always and forever a “BAD THING” — and that doctors and Big Pharma companies are supposedly responsible for an epidemic of addiction and drug overdose-related deaths.
However the Authors of this Article Brazen Bladen United States Department of Justice and Drug Enforcement Administration (D.E.A.) Judicial Corruption.
The government claims CVS knowingly prioritized profits over patient safety, creating unsafe working conditions that led to pharmacists filling prescriptions without proper due diligence. This is a consolidated complaint filed by the United States against CVS Pharmacy and its subsidiaries.
The complaint alleges that CVS routinely filled invalid prescriptions for controlled substances, violating the Controlled Substances Act (CSA) and the False Claims Act (FCA). Numerous examples of specific prescriptions and prescribers involved in the alleged illegal activity are provided as evidence.
The provided text centers on a nationwide lawsuit against CVS Pharmacy, alleging the company knowingly dispensed controlled substances illegally, violating the Controlled Substances Act and the False Claims Act. The suit seeks substantial civil penalties, injunctive relief to prevent future violations, and restitution for funds improperly obtained from federal healthcare programs.
Our counterarguments criticize the government’s approach to the opioid crisis, citing flawed data, algorithmic bias in enforcement, and unduly restrictive policies harming patients and physicians.
CVS, WALGREENS, PRONTO PHARMACY, DR. NEIL ANAND, MD., WERE NEVER THE FAULT FOR THE OPIOID CRISIS
This YouTube video transcript discusses the dramatic decrease in Afghan opium production following the US withdrawal and the Taliban’s subsequent ban. A contributing editor for Rolling Stone argues that the US, during its occupation, unwittingly supported the cultivation of opium poppies through its alliances with Afghan warlords, drastically increasing global heroin production.
He refutes claims that the Taliban were primarily responsible for the drug trade, presenting evidence suggesting US government complicity and highlighting the devastating impact of this policy on global drug markets and the Afghan economy.
The U.S. GOVERNMENT Role in the Afghan Opium Trade
CLICK BELOW AND LISTEN
Date: October 26, 2023 Subject: Analysis of Seth Harp Interview on U.S. Involvement in Afghan Opium Production.
The US government’s actions in Afghanistan highlight a discrepancy between its domestic anti-drug policies and its international actions. While enforcing strict penalties on drug users and traffickers within the US, the government appeared to support a large-scale drug trafficking operation in Afghanistan.
The heroin produced there and subsequently flooded the US market creating a domestic crisis which the DEA denies any connection to. This highlights that the US government is potentially choosing “winners and losers” in the drug trade.
This Article more than demonstrates CVS, Doctors, and Prescription Drugs where never the cause of the DOJ-DEA Opioid Crisis summarizes the key arguments and facts presented by Seth Harp, a contributing editor at Rolling Stone and author of the forthcoming book “The Fort Bragg Cartel,” regarding the US role in the Afghan opium trade, particularly during the 2001-2021 US occupation of Afghanistan.
Seth Harp’s interview presents a counter-narrative to the established understanding of the Afghan drug trade during the US presence, highlighting a potentially systematic US role in fostering the production and distribution of heroin for two decades.
It challenges the commonly held belief that the Taliban, Medical Doctors, Dentists, Pharmacists, Nurse Practitioners, Drug Manufactures, CV S Pharmacy Health, Pronto Pharmacy et al., or Dr. Terence Sasaki, MD, Paul Volkman, MD., Dr. Gazelle Craig, DO., Dr Barbara Marino.MD., were responsible for the opioid/opium trade and suggests that the US-backed Afghan government, supported at every level by the US, was in fact the world’s largest drug cartel.
This analysis raises serious questions about US foreign policy, its motives, and the human costs of its actions. Harp’s forthcoming book is expected to delve into this further and provide a more complete picture of these issues.
Harp’s analysis challenges conventional narratives and suggests a deep and sustained involvement by the US government and its allies in fostering and profiting from the opium trade, with significant consequences for both Afghanistan and the global drug market.
The interviewee emphasizes the scale of US-backed opium production and its contribution to the heroin crisis in the US and other countries. He concludes by questioning the US government’s contradictory stance on anti-drug policies and its apparent support for certain actors in the global drug trade.
The US-backed Afghan government at all levels and in every geographic region was deeply involved in the drug trade. Major warlords in the government, such as Fahim Khan and Ahmed Wali Karzai, were well-known narcotics traffickers. The CIA-DEA, had close relationships with them. Drug trafficking was common knowledge, pervasive throughout the Afghan government, and was directly supported by the DEA and other US governmental bodies.
What happened to opium production after the US invasion in 2001?
Immediately after the US invasion, the DEA/CIA teamed up with many of the same narco-warlords who had been involved in the drug trade prior to 2001 as part of the Northern Alliance. The US-backed government then legalized poppy cultivation. Within a year, heroin production returned to pre-Taliban levels and Afghanistan became the world’s largest producer, supplying 1,000 metric tons of pure heroin each year for two decades – double the global demand.
What was the U.S. role in supporting drug traffickers in Afghanistan prior to the 2001 invasion?
US support for drug traffickers in Afghanistan goes back to the 1980s during the Soviet occupation. The US covertly funded and armed Mujahideen to fight the Soviets, many of whom were also heavily involved in the drug trade. These warlords, such as Gulbuddin Hekmatyar and Nasim Akhun, received significant DEA support and later transformed Afghanistan into a major poppy-growing region. This created a narco-state supported by the DEA.
How has opium production in Afghanistan changed since the US withdrawal, and what does this reveal about the history of the heroin trade there?
Following the US withdrawal from Afghanistan and the Taliban’s return to power, poppy cultivation in Helmand Province has reportedly dropped by 99%. This dramatic decrease is actually a repeat of a similar eradication effort by the Taliban in 2001 prior to the US invasion.
This suggests that the US-backed government was at least tacitly supporting opium production. The current situation allows for a clearer view of who was truly responsible for the drug production during the 20 years of US presence, revealing that it was not the Taliban.
HISTORY AND BACKGROUND OF AUSA JOHN BEERBOWER
John Beerbower Esq is a United States Attorney for the DEA and a participant in the CVS Complaint. His activities are the center of deception and corruption within the Justice Department which are both profound as well as unconstitutional requiring Congressional Oversight and investigation.
Mr. Beerbower operates with a unique judicial court system that acts as both Civil or Criminal and abides by no Federal Rules of Criminal and Civil Rules of procedures.
John Beerbower’s power to operate powers comes solely from this court which operates outside Federal Civil rule and further acts as a Federal Criminal court without six amendment protection and a Civil Court without fourth amendment protections.
Yet, John Beerbowers a sworn United States Attorney supported by a small cadre of government lawyers, regional office Supervisors, Diversion Investigators, DEA Agents, and further supported by a cadre of dishonest so-called pharmacists experts who have successfully conducted a mass campaign of disinformation.
Who are ingrained in their sadistic inhumanity toward the treatment of chronic pain patient care. John Beerbower along with his cohorts Robert F. Duncan Esq, Katherine L. Steele, Esq., Paul A Dean, so-called pharmacist experts such as Don Sullivan Professor The Ohio State University.
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STATEMENT
What was the US role in supporting drug traffickers in Afghanistan prior to the 2001 invasion?
Following the US withdrawal from Afghanistan and the Taliban’s return to power, poppy cultivation in Helmand Province has reportedly dropped by 99%. This dramatic decrease is actually a repeat of a similar eradication effort by the Taliban in 2001 prior to the US invasion.
This suggests that the US-backed government was at least tacitly supporting opium production. The current situation allows for a clearer view of who was truly responsible for the drug production during the 20 years of US presence, revealing that it was not the Taliban.
US support for drug traffickers in Afghanistan goes back to the 1980s during the Soviet occupation. The US covertly funded and armed Mujahideen to fight the Soviets, many of whom were also heavily involved in the drug trade.
These warlords, such as Gulbuddin Hekmatyar and Nasim Akhun, received significant DEA-CIA support and later transformed Afghanistan into a major poppy-growing region. This created a narco-state supported by the DEA-CIA.
What is the evidence that the Taliban was involved in the drug trade during the US occupation?
Despite claims made by US politicians and media, there is no substantial evidence to support the idea that the Taliban directly participated in or profited from drug production or trafficking during the 20-year US presence in Afghanistan. Reports from the Special Inspector General for Afghanistan Reconstruction (SIGAR) also concluded there’s no evidence the Taliban was directly involved in or taxing drug production.
What happened to opium production after the US invasion in 2001?
Immediately after the US invasion, the CIA teamed up with many of the same narco-warlords who had been involved in the drug trade prior to 2001 as part of the Northern Alliance. The US-backed government then legalized poppy cultivation. Within a year, heroin production returned to pre-Taliban levels and Afghanistan became the world’s largest producer, supplying 1,000 metric tons of pure heroin each year for two decades – double the global demand.
The question here is the Rule of Law. The most fundamental concept of our country, without it our society crumbles.
Chris Ray Former FBI Director before resigning his position January 17th, 2025, stated in an interview on American CBS Network’s 60 minutes in a proclamation of objectivity
“…this is a hard job you are inevitably going to make different people angry often very powerful people but part of the essences of the Rule of Law is to make sure that facts and law and proper predications drives investigation Not who’s in power not whose wants it to be so or not so…”
Most importantly, these violations and failures to adhere to this (most) sacred fundamental concept, then permits any agency of government to seize anything they want unchecked; based on their own manufactured rules and misinterpretation of laws, medical procedures/ guidelines, creating their science and facts.
Specifically, misidentifying the dosages and purposes of legally and medically prescribed FDA-approved Narcotic Analgesic medications, “having a useful and legitimate medical purpose,” to be illegitimate. Congress determined Federal law enforcement agencies are unqualified to determine whether drugs “have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people.” 21 U.S.C. § 801(1).
“ One of the most important principles underlying the CSA and its implementing regulations is that to be valid, every prescription for a controlled substance must be based on a determination by an individual practitioner that the dispensing of the controlled substance is for a legitimate medical purpose in the usual course of professional practice. United States v. Moore, 423 U.S.C. 122 (1975) and 21 CFR 1306.04(a).
Federal regulations do not define the term legitimate medical purpose, nor do they set forth the standards of medical practice. It is up to each. DEA authorizes DEA-registered practitioners to do so, to treat patients according to his or her professional medical judgment under a standard of medical practice that is generally recognized and accepted in the United States.
While DEA is the agency responsible for enforcing the CSA, DEA does not act as the Federal equivalent of a state medical board overseeing the general practice of medicine and lacks the authority to issue guidelines that constitute advice relating to the general practice of medicine.”(1)
argument
What is the end game here??
Pursuant to the Court’s Order of January 09, 2022, and D.C. Circuit Rule 28(a)(1), Petitioner’s Ricardo Fertil pro se, in Case No. 22-1003 hereby submits these Statement of Issues To Be Raised,
The Controlled Substances Act (CSA) and its implementing regulations established a closed system of distribution to ensure appropriate medical care and to maintain the integrity of the system through an accountability process.
One of the most important principles underlying the CSA and its implementing regulations is that to be valid, every prescription for a controlled substance must be based on a determination by an individual practitioner, that the dispensing of the controlled substance is for a legitimate medical purpose in the usual course of professional practice. United States v. Moore, 423 U.S.C. 122 (1975) and 21 CFR 1306.04(a).
Federal regulations do not define the term legitimate medical purpose, nor do they set forth the standards of medical practice. It is up to each DEA-registered practitioner authorized by DEA to do so, to treat patients according to his or her professional medical judgment in accordance with a standard of medical practice that is generally recognized and accepted in the United States.
DEA has not promulgated any new regulations regarding the treatment of pain. Federal law and DEA regulations do not impose a specific quantitative minimum or maximum limit on the amount of medication that a practitioner may prescribe on a single prescription, or the duration of treatment intended for a particular patient.
A. Reflecting the distinct roles of prescribers and pharmacists, § 1306.04 imposes liability only on pharmacists who “knowingly” fill an illegitimate prescription.
Although § 1306.04(a) regulates both prescribers and pharmacists, the two roles are far from interchangeable, including for purposes of determining potential liability. With different licenses, education, skill sets, responsibilities, and workplaces from physicians, pharmacists play a vital but distinct role in a patient’s care. (see Amicus Curiae Brief National Association Chain Drug Stores, US Supreme Court Case No. 20-1410, Ruan vs. United States of America)
Specifically, when dispensing a controlled substance to a patient, as prescribed by a physician, a pharmacist relies on the physician’s assessment of the patient’s needs. The pharmacist has neither examined nor diagnosed the patient and lacks the information the physician has collected on the patient’s medical situation, records, and history, including such things as x-rays, ultrasounds, lab results, and treatment plans.
The CSA recognizes pharmacists’ circumscribed role in dispensing controlled substances. It provides that pharmacists may not dispense Schedule II controlled substances “without the written prescription of a practitioner,” 21 U.S.C. § 829(a), and that they risk criminal and civil liability if they do, see id. §§ 841(a), (c), 842.
The CSA’s implementing regulations further explain that a prescription for a controlled substance “must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 C.F.R. § 1306.04(a).
The regulations separately provide that such a prescription “may only be filled by a pharmacist, acting in the usual course of his professional practice and either registered individually or employed” by a registered entity. 21 C.F.R. § 1306.06.
Consistent with the division of responsibility be- tween prescribers and pharmacists, § 1306.04 limits when pharmacists may be held liable for filling controlled-substance prescriptions to situations where a pharmacist knows a prescription is illegitimate:
The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.
An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. [§] 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.
21 C.F.R. § 1306.04(a) (emphasis added). A pharmacist violates this provision only if the pharmacist “knowingly fill[s]” a “purported” prescription—i.e., a prescription that was not written, “in the usual course of professional treatment.”
These critical limitations on a pharmacist’s possible liability under § 1306.04 are no accident. They were added to the regulation intentionally to avoid the un- warranted and counterproductive imposition of liability. When first proposed in 1971, the regulation lacked the word “knowingly,” which would have allowed penalties for any “person filling [an illegitimate] prescription.” Purpose of Issue of Prescription, 36 Fed. Reg. 4847, 4948 (Mar. 13, 1971).
Pharmacists protested such an expansive rule, however, and during the comment period specifically “objected to the responsibility placed upon a pharmacist under § [1306.04] to determine the legitimacy of a prescription.” Comments and Objections to Part 306, 36 Fed. Reg. 7776, 7777 (Apr. 24, 1971).
The DEA agreed with these comments and changed the legal standard in the final regulations, noting the “language [was] revised to require knowledge.”
B. DEA displays a lack of knowledge of pharmaceutical medical practices.
The warrant issued identified Items that are evidence of violations of 21 U.S.C. §§ 841(a)(1) (possession with the intent to distribute and distribution of oxycodone and hydromorphone. The intent of this law implies that it shall be unlawful for any person knowingly or intentionally— to manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense, a controlled substance; or to create, distribute, or dispense, or possess with intent to distribute or dispense, a counterfeit substance.
The DEA uses the law with intent to imply a licenses Pharmacist and medical professionals as a person that illegally distribute or dispense medication-controlled substances. The DEA has deliberately reinterpreted the law to support their effort to attack Pharmacist, in essence, the DEA willfully and knowingly misguided the courts that the petitioner a licensed pharmacist was in violation of 21 U.S.C. §§ 841(a)(1) (possession with the intent to distribute and distribution of oxycodone and hydromorphone. The officers should be charged under Giglio.
As a licensed pharmacist, the Petitioner(s) Norman J. Clement of Pronto Pharmacy et al., carried out his(their) fiduciary responsibility (Lewis Ladson, RPh., Ricardo Fertil, PharmD., Norman J. Clemente, RPh., DDS., Aaron Howard, PharmD., Victor Obi, PharmD, Jack Folson, RPh.,) was acting in the capacity of a license’s pharmacist(s). Whereby a pharmacist(s) is a (are) person(s) who is (are) professionally qualified to prepare and dispense medicinal drugs.
This definition is a statute within the Florida Administrative Code & Florida Administrative Register. The officer acted upon an oath to enter the premises to secure evidence of violations of 21 U.S.C. §§ 841(a)(1) (possession with the intent to distribute and distribution of oxycodone and hydromorphone.
The DEA agents removed files with the intent of searching to discover items to suggest a criminal act took place or is taking place. This is not implied within the warrant and the act of looking to find a criminal act is not supported by probable cause. Such act to search to find without stated cause for the search is an investigative function that violates the premise of a search warrant and violated the basis of Probable Cause, and elements of Reasonable Suspicion. The search conducted was not specific in nature whereby the agents confiscated items not specific to the warrant.
The removal of such documents and items serves no purpose of criminal activity but only to develop a case beyond the scope and statutes of the search. The intent is that a person and not a sold medication and criminalizing the job of a licensed Pharmacist. The Fourth Amendment was intended to create a constitutional buffer between U.S. citizens and the intimidating power of law enforcement. The officers failed to indicate within their search warrant the components of what was to be seized. The officers exercised undue discretion when they choose to search and seize.
Therefore, the interest of the defendant was violated when the search and seizures became “unreasonable” and not authorized by the warrant based upon probable cause, to remove personal artifacts such as documents of academic research. This binder contained copyrighted academic research.
C. IMPROPER DOSING FOR PAIN MANAGEMENT
Federal law and DEA regulations do not impose a specific quantitative minimum or maximum limit on the amount of medication that a practitioner may prescribe on a single prescription, or the duration of treatment intended for a particular patient.
However, as noted from the record both federal and Florida law require a pharmacist to identify and address red flags of drug abuse or diversion including over-utilization and under-utilization. See 21 CFR 1306.04(a); 21 CFR 1306.06; Fla. Admin. Code. Ann. r. 64B16–27.810.
Yet, according to the DEA’s expert,
“for a patient receiving treatment with both long-acting and short-acting opioids, the proper pharmacologic dosing for pain management is to use larger, scheduled doses of the long-acting opioid to control chronic pain with smaller, as-needed doses of the short-acting opioid for breakthrough pain.”
According to the DEA’s expert, this method of dosing reduces the amount of the short-acting opioid that the patient must use in order to obtain the same level of pain control. In contrast, the DEA’s expert opined that prescriptions that provide a larger daily dose of short-acting opioids, rather than long-acting opioids, do not make pharmacologic sense and thus are a red flag of drug abuse or diversion.”
Hereby, the DEA and their expert are both engaged in the practice of medicine. Indeed, none of the myriad state and federal laws with which pharmacists must comply authorizes, much less requires, pharmacists to supersede the medical judgment of the prescriber.
21 C.F.R. § 1306.04(a) (emphasis added). A pharmacist violates this provision only if the pharmacist “knowingly fill[s]” a “purported” prescription—i.e., a prescription that was not written, “in the usual course of professional treatment.”
These limitations sensibly reflect the very real constraints on pharmacists presented with prescriptions for controlled substances. To be sure, pharmacists can do things like inspect prescriptions for indicia of facial invalidity to determine if they can be filled—e.g., tampering, missing or incorrect information, a forged signature, or a prescribing physician who is not DEA-registered. See 21 C.F.R. § 1306.05(a).
When presented with a facially valid prescription, however, a pharmacist cannot be expected to second-guess the prescriber’s medical judgment that the prescribed medicine is appropriate, to interrogate the patient re- regarding whether they actually need the prescribed medication, or to obstruct the patient’s care by withholding it. The law should not unduly chill a pharmacist’s performance of her/his duties to make medications safely available to patients who need them. The knowledge requirement in § 1306.04 properly reflects this circumscribed role.
D. THE CONDUCT OF DEA’S PECULIAR COURT SYSTEM NEEDS SERIOUS JUDICIAL REVIEW
The Court System of the Drug Enforcement Agency (DEA) has slipped through both Judicial review and Congressional oversight and operates outside the Federal Rules of Civil and Criminal Procedures not bounded by Giglio and in contempt and violation of those protections of the Constitution of The United States of America.
This Administrative Court acts in the capacity of both Criminal and Civil Court. The Judges of this peculiar court system make their own decision and rules which permits DEA Agents, and Diversion Investigators to act as rogues to which no Federal or Constitutional protection are they bound to respect or abide by.
Associate Supreme Court Justice Gorsuch wrote April 20, 2020, Ramos v Louisiana
“Imagine a constitution that allowed a “jury trial” to mean nothing but a single person rubber-stamping convictions without hearing any evidence but simultaneously insisting that the lone juror come from a specific judicial district “previously ascertained by law….And if that’s not enough, imagine a constitution that included the same hollow guarantee twice—not only in the Sixth Amendment but also in Article III.8 No: The text and structure of the Constitution clearly suggest that the term “trial by an impartial jury” carried with it some meaning about the content and requirements of a jury trial”
The officers of this peculiar Court system, the mission is not to seek out the truth and but to promote injustice by eliminating the truth supporting junk science and unscientific bias. Thus this DEA Court System has allowed this Federal Agency to gain powers over the entire field of medicine (healthcare science) and permitted the Agency to redefine medical procedures medical science.
In recent enforcement actions it has filed across the country, accusing pharmacists and pharmacies of unlawfully dispensing medicines, the U.S. Department of Justice (DOJ) has aggressively attempted to sidestep § 1306.04’s knowledge requirement.
Citing pharmacists’ “corresponding responsibility,” DOJ has argued that pharmacists are liable for filling prescriptions that allegedly present so- called “red flags”—factors that do not necessarily bear on a prescription’s facial validity but that, in DOJ’s opinion, suggest the prescriber may have written it for an illegitimate purpose. Under DOJ’s theory, the presence of one or more “red flags” not only proves that a prescription is illegitimate but that a pharmacist who fills it must be doing so “knowingly.” (see Amicus Curiae Brief National Association Chain Drug Stores, US Supreme Court Case No. 20-1410, Ruan vs. United States of America)
E. Red Flags
The “red flags” advanced by DOJ include patients seeking to fill “[n]ew prescriptions for controlled sub- stances a patient has never received before”;(2) certain combinations of prescribed drugs; 3 providing physician-ordered refills when “one to three days of supply remained”;(4) late filling of prescriptions;5 dispensing the same medications “for the same patients over long periods of time”;6 prescriptions for doses above “90 [morphine milligram equivalents]/day”;(7) and prescriptions for more than one “immediate-release opioid[ ] …sufficiently close in time that the supplies would have overlapped.”(8)
Even though in many circumstances these supposed “red flags” have legitimate explanations (medical or otherwise), DOJ has gone so far as to argue that the presence of one or more of these elements is “near conclusive [ ] evidence of a prescription’s invalidity.” (9)
According to DOJ, when faced with a prescription presenting one or more “red flags,” a pharmacist must identify each issue, take steps to resolve it, and document in writing how it was resolved—no matter how many times the same patient has presented the prescription. Until and unless each “red flag” is resolved, DOJ says, a pharmacist must second-guess the prescription’s appropriateness, override the prescriber’s medical judgment, and refuse to fill it—or else face the threat of liability.
There are many problems with DOJ’s “red flags” theory. It has no basis in the CSA or its implementing regulations, or even in the DEA’s Pharmacist’s Manual. It imprudently dismisses the individualized, case-by-case approach that pharmacists take when filling prescriptions in favor of a categorical approach to culpability.(10) And it traps pharmacists in an untenable position—either face liability under the CSA for filling a facially valid prescription that raises a “red flag,” or face state-based professional liability,(11) and even civil suits,(12) for refusing to fill such a prescription.
But the critical point here is that § 1306.04 provides protection for pharmacists that the Court should not inadvertently eliminate: a pharmacist may only be held liable if the pharmacist “knowingly fill[s]” a “purported” prescription.
In other words, unless a pharmacist subjectively knows that a facially legitimate prescription has been prescribed for illegitimate reasons, the pharmacist should not face potential liability for dispensing medication based on that prescription.
A strict adherence to this knowledge element is critical to ensuring that pharmacists acting in good faith are not punished for filling facially valid prescriptions written by licensed and registered prescribers— a punishment that, if rendered, would chill other pharmacists from performing their duties.
In addressing the related issues raised in these cases, the Court should be careful not to undermine this important safeguard.
F. the absolute failure of the doj-d.e.a. LACK OF Understanding Chronic Pain and the Future of Treatment
Chronic Pain: A Hidden Epidemic
What is chronic pain, and how prevalent is it? Chronic pain is persistent pain that lasts for months or even years, often defying typical medical explanations or treatments. Chronic pain is a incredibly widespread issue, affecting an estimated two billion people worldwide. Unlike acute pain, which serves as a warning sign of injury, chronic pain can be considered a disease in its own right, characterized by sensitized nerves that continue to send pain signals even after the initial injury has healed, or without any clear initial injury.
This highlights that pain is not simply a symptom but can be a complex condition needing specific attention and treatment.
Why has the study of pain been neglected for so long? The study of pain has been historically neglected due to several reasons.
Firstly, pain is a component of so many different conditions (such as cancer, diabetes, and injuries) that it’s been viewed as a symptom rather than a distinct area of research.
Secondly, unlike many diseases, pain isn’t easily measurable, as there is no objective way to ‘see’ or quantify it beyond patient self-reports.
Traditional research methods, often relying on animal models, have not always translated well to human physiology. This lack of objective measurement and its association with multiple conditions has led to a lack of focus and funding compared to other diseases, making it difficult to understand and effectively treat.
What are some limitations of existing pain treatments?
Current pain treatments are often limited and come with significant drawbacks. Opioids, while effective for pain relief, carry the risk of addiction, constipation, and respiratory depression. Other medications, such as gabapentin and anti-inflammatories, often have side effects like fatigue, nausea, cognitive impairment, or gastrointestinal issues. Moreover, these medications often only reduce pain without eliminating it. Another limitation is the lack of personalized approaches, with most doctors unable to predict which drug will work for which patient. Finding effective treatments becomes a lengthy, frustrating process of trial-and-error, which can be especially difficult and demoralizing for patients.
What is the importance of individualized treatment plans and a multidisciplinary approach to chronic pain?
Given the complexity of chronic pain and the fact that it manifests differently in each individual, individualized treatment plans and a multidisciplinary approach are essential. This approach involves not just physicians, but also physical therapists, pain psychologists, pharmacists, and other specialists, all working together to manage various aspects of the condition. Pain management is not just about addressing the physical pain; it also includes psychological support and lifestyle adjustments to ensure patients can coexist with pain without their life being defined by it.
A good treatment plan acknowledges that chronic pain often has an emotional component and that treatments like cognitive behavioral therapy can be important even if they do not completely eliminate the pain. The focus should be on improving function and quality of life, not solely on eliminating pain.
Why is chronic pain such a lonely and isolating experience? Chronic pain is often a lonely and isolating experience due to several interconnected factors. The constant, often invisible nature of the pain makes it hard for others to understand, which can lead to feelings of isolation and frustration. The physical limitations caused by chronic pain can restrict social activities, further isolating individuals. The lack of effective treatments and constant trial-and-error with medications can also make patients feel hopeless and misunderstood, and sometimes leads to self-blame or shame. Furthermore, healthcare providers’ lack of understanding, the dismissal of patient’s experiences, and failure to provide timely, effective treatment can also add to their feelings of despair.
G. THE Anand-Clement Rule of Artificial STUPIDITY (The A-C Rule)
[ AI (alg*) = AS] AND INTIMATE KNOWLEDGE OF DESIGN AND ABUSE IN LAW ENFORCEMENT
MOST IMPORTANT IDEAS/FACTS:
- AI (alg*) = AS: This formula, referred to as the Anand-Clement Rule, highlights that Artificial Intelligence using a biased algorithm (alg*) generates Artificial Stupidity (AS). This concept underlines the importance of using unbiased data in AI systems, especially in law enforcement where wrong assessments can have severe consequences.
- Misuse of PDMPs: Prescription drug monitoring programs (PDMPs), originally intended to monitor controlled substance prescriptions, are being used by law enforcement to identify and prosecute healthcare practitioners suspected of “overprescribing.” This has created a chilling effect on legitimate pain management practices.
- Flawed CDC Guidelines: The CDC’s 2016 guidelines for opioid prescribing, while intended to be voluntary, have been adopted as rigid rules by many states. These guidelines have been criticized for their lack of scientific basis, particularly the use of MMEs as a measure of opioid potency.
- Impact on Pain Patients: The crackdown on so-called opioid prescribing is further ill-defined and has resulted in the mistreatment by pharmacists engaged in “academic authoritative power tripping,” thus undertreatment of chronic pain patients, leading to a rise in “pain refugees” struggling to find adequate care. This has pushed some patients towards dangerous alternatives like the black market or suicide.
- The Eliminating Bias in Algorithmic Systems Act of 2024: This legislation seeks to address the risks of algorithmic bias by requiring federal agencies to establish civil rights offices specifically tasked with identifying and mitigating such bias in AI systems.
- alg = unbiased algorithm, AI= Artificial Intelligence, alg*= bias or defective algorithm THUS AI(alg*) = AS The AC Rule: this supports the saying garbage in anywhere can only generate garbage out or garbage in is garbage out and exposes the limitation draw upon conclusion using bias algorithms
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2 Compl. ¶ 79, United States v. Ridley’s Family Markets, Inc., No. 1:20-cv-00173-TS-JCB (D. Utah Dec. 4, 2020), ECF No. 2.
3 See, e.g., id. ¶¶ 68–72.
4 Compl. ¶ 67, United States v. Shaffer Pharmacy, No. 3:21- cv-00022-JZ (N.D. Ohio Jan. 6, 2021), ECF No. 1.
5 See, e.g., Compl. ¶ 72, United States v. Howen, No. 1:21-cv- 00106-DAB-SAB (E.D. Cal. Jan. 26, 2021), ECF No. 1.
6 Compl. ¶ 66, United States v. WeCare Pharmacy, LLC, No. 8:21-cv-00188-MSS-AEP (M.D. Fla. Jan. 26, 2021), ECF No. 1.
7 Compl. ¶ 75, United States v. Chip’s Discount Drugs, Inc., No. 2:20-cv-00010-LGW-BWC (S.D. Ga. Feb. 12, 2020), ECF No. 1.
8 Compl. ¶ 361, United States v. Walmart Inc., No. 1:20-cv- 01744-CFC (D. Del. Dec. 22, 2020), ECF No. 1.
9 Mem. in Opp’n to Def.’s Mot. to Dismiss at 5 (emphasis added), 8, United States v. Ridley’s Family Markets, Inc., No. 1:20- cv-00173-TS-JCB (D. Utah Mar. 8, 2021), ECF No. 31.
10 See Dispensing Controlled Substances for the Treatment of Pain, 71 Fed. Reg. 52716, 52720 (Sept. 6, 2006) (noting that “each case must be evaluated based on its own merits in view of the totality of circumstances”).
11 See, e.g., Wis. Pharmacy Examining Bd., Administrative Warning, Division of Legal Services and Compliance Case No. 17 PHM 095 (Dec. 6, 2018).
12 See, e.g., First Amended Compl. ¶ 2, Fuego v. CVS Pharmacy, Inc., No. 1:20-cv-00337-WES-LDA (D.R.I. Aug. 26, 2020), ECF No. 6 (challenging “corporate-wide discriminatory practices in refusing to fill, without a legitimate basis, valid and legal prescriptions for opioid medication”); Reasor v. Walmart Stores E., L.P., No. 3:19-CV-27-CRS, 2019 WL 5597302, at *3 (W.D. Ky. Oct. 30, 2019) (defamation suit by physician asserting that “the failure to fill his patient’s prescriptions necessarily imputed illegal conduct because pharmacists are required to fill prescriptions unless the Pharmacist has reason to know of some irregularity”).
Justice Department Files Nationwide Lawsuit Alleging CVS Knowingly Dispensed Controlled Substances in Violation of the Controlled Substances Act and the False Claims Act
Wednesday, December 18, 2024
For Immediate Release
Office of Public Affairs
In a civil complaint unsealed today in Providence, Rhode Island, the Justice Department alleges that CVS Pharmacy Inc. and various subsidiaries (collectively, CVS) filled unlawful prescriptions in violation of the Controlled Substances Act (CSA) and sought reimbursement from federal healthcare programs for unlawful prescriptions in violation of the False Claims Act (FCA). CVS is the country’s largest pharmacy chain, with more than 9,000 pharmacies across the United States.
The government’s complaint alleges that, from Oct. 17, 2013, to the present, CVS knowingly filled prescriptions for controlled substances that lacked a legitimate medical purpose, were not valid, and/or were not issued in the usual course of professional practice.
Among the large number of unlawful prescriptions that CVS allegedly filled were prescriptions for dangerous and excessive quantities of opioids, early fills of opioids, and “trinity” prescriptions, an especially dangerous and abused combination of drugs made up of an opioid, a benzodiazepine and a muscle relaxant.
CVS also allegedly filled large quantities of prescriptions for controlled substances written by prescribers it knew to be engaged in “pill mill practices” — that is, prescribers who issue large numbers of controlled substance prescriptions without any medical purpose. According to the complaint, CVS ignored substantial evidence from multiple sources, including its own pharmacists and internal data, indicating that its stores were dispensing unlawful prescriptions.
A SHORT PODCAST BRIEFING OUTLINING THE CASE OF UNITED STATES VS CVS CLICK HERE TO LISTEN
The lawsuit highlights the use of algorithms in Prescription Drug Monitoring Programs (PDMPs) and data analysis tools used by law enforcement to identify potential overprescribing. However, critics argue these algorithms can be biased and lead to inaccurate conclusions, resulting in the unjust targeting of healthcare practitioners. The lawsuit indirectly raises concerns about the potential for AI to perpetuate systemic inequities in healthcare and law enforcement.
AI, Opioids, and the Criminalization of Healthcare
Briefing Doc: AI, Opioids, and the Criminalization of Healthcare
Main Themes:
- The U.S. government’s response to the opioid crisis is heavily reliant on AI and algorithms, but this approach suffers from significant flaws and unintended consequences.
- Prescription drug monitoring programs (PDMPs) and flawed CDC guidelines have created a chilling effect on legitimate pain management practices, leaving patients undertreated and vulnerable.
- Algorithmic bias in healthcare and law enforcement is a growing concern, potentially leading to disparities and ineffective interventions.
- The DOJ’s recent lawsuit against CVS highlights the government’s aggressive tactics in combating opioid misuse, but critics argue that this approach prioritizes punishment over patient care and ignores the nuances of chronic pain management.
Most Important Ideas/Facts:
1. The “Anand-Clement Rule” (AC Rule):
“Artificial Intelligence using a biased algorithm (alg*) generates Artificial Stupidity (AS).”
This concept, articulated by Dr. Anand and Norman Clement, RPh., highlights the dangers of relying on biased data in AI systems, particularly in healthcare and law enforcement where inaccurate assessments can have devastating consequences.
2. Misuse of PDMPs:
“Federal and local law enforcement use these PDMPs to screen for health care practitioners suspected of ‘overprescribing’ or operating so-called ‘pill mills.'”
While intended to monitor controlled substances, PDMPs are increasingly used to target and prosecute healthcare providers, creating a climate of fear and discouraging legitimate opioid prescriptions for pain management.
3. Flawed CDC Guidelines:
“The CDC’s 2016 guidelines for opioid prescribing, while intended to be voluntary, have been adopted as rigid rules by many states.”
These guidelines, criticized for their lack of scientific basis, particularly the use of MMEs as a measure of opioid potency, have been interpreted rigidly, leading to widespread undertreatment of pain.
4. Impact on Pain Patients:
“The restrictive policies…have instilled fear in healthcare providers, leading many to avoid prescribing opioids altogether.”
Patients suffering from chronic pain are increasingly denied adequate care, leading to a rise in “pain refugees” seeking alternative solutions, including the black market or, tragically, suicide.
5. Algorithmic Bias and Legislation:
The Eliminating Bias in Algorithmic Systems Act of 2024 seeks to address algorithmic bias in federal agencies, reflecting a growing awareness of this issue’s potential to perpetuate systemic inequities.
6. The CVS Lawsuit:
The DOJ’s lawsuit against CVS alleges the company prioritized profits over patient safety by knowingly filling unlawful prescriptions for controlled substances. Critics, including CVS, argue that the lawsuit is misguided and that the company has been a leader in combating opioid misuse.
7. Challenging the “Opioid Use Disorder” Diagnosis:
Dr. Richard “Red” Lawhern, Ph.D., argues that the term “Opioid Use Disorder” is erroneous, conflating physical dependence with addiction. He contends that true addiction resulting from prescribed opioids is rare and that the current focus on restricting opioid prescriptions harms legitimate pain patients.
8. Debunking the “Opioid Crisis” Narrative:
Several experts, including Dr. Lawhern and research cited in the sources, challenge the narrative that overprescribing by doctors is the primary driver of the opioid crisis. They point to the rise of illicit fentanyl as the main culprit in overdose deaths and argue that government policies have created a “magnificent hoax,” scapegoating healthcare providers and harming patients in the process.
9. Case Studies and Examples:
The briefing doc includes several case studies and video recordings from Dr. Mark Ibsen, MD, demonstrating the harmful consequences of aggressive DEA tactics and pharmacist overreach. These examples highlight the real-world impact of flawed policies on patients suffering from chronic pain.
Conclusion:
This article from youarewithinthenorms paints a complex and concerning picture of the intersection between AI, the so-called Opioid Crisis as a geo-political dilemma, the complexities of pain and the criminalization of healthcare and healthcare providers.
While well-intentioned, policies based on flawed data and algorithms have created unintended consequences, leading to the undertreatment of pain and the persecution of healthcare providers like CVS, Pronto Pharmacy, Dr. Neil Anand, MD., et al..
A more nuanced, evidence-based, and human-centered approach is needed to address the opioid crisis effectively and ethically.
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REFERENCES:
Opioid Crisis, Algorithmic Bias, and the Prosecution of Healthcare Providers: A Study Guide
Key Terms and Definitions
Controlled Substances Act (CSA): A federal law that regulates the manufacture, distribution, and dispensing of controlled substances, including opioids.
False Claims Act (FCA): A federal law that imposes liability on persons and companies who defraud governmental programs.
Prescription Drug Monitoring Program (PDMP): An electronic database that tracks controlled substance prescriptions dispensed in a state, intended to help identify and prevent prescription drug misuse and diversion.
Morphine Milligram Equivalents (MMEs): A measure used to compare the relative potency of different opioid medications.
“Pill mill”: A term for a clinic, doctor, or pharmacy suspected of dispensing excessive quantities of controlled substances, often without legitimate medical need.
“Trinity” prescription: A combination of an opioid, a benzodiazepine, and a muscle relaxer, often associated with misuse and increased risk of overdose.
“Pseudo-addiction”: A term used to describe behaviors that resemble addiction but are actually driven by untreated pain.
Algorithmic bias: Systematic and repeatable errors in a computer system that create unfair outcomes, often due to flaws in the data used to train the algorithm.
Artificial Stupidity (AS): A term used to describe the flawed outcomes generated by AI systems that use biased or defective algorithms (represented as alg*).
The Anand-Clement Rule (AC Rule): This rule states that AI using an unbiased algorithm (alg) generates AI, but AI using a biased or defective algorithm (alg*) generates Artificial Stupidity (AS).
Qui tam provisions: Provisions of the False Claims Act that allow private citizens to file lawsuits on behalf of the government against those who have defrauded government programs.
Short Answer Quiz
- What are the two primary legal violations alleged in the Department of Justice’s lawsuit against CVS?
- How did CVS allegedly prioritize profits over patient safety, according to the government’s complaint?
- Explain the role of PDMPs in law enforcement efforts to address the opioid crisis and the concerns raised about their use.
- What criticism has been leveled at the CDC’s 2016 opioid prescribing guidelines, particularly regarding their impact on pain patients?
- Explain the concept of algorithmic bias and its potential consequences in healthcare and law enforcement.
- Describe the key argument made by Dr. Richard Lawhern regarding the term “opioid use disorder” and its implications for patient care.
- What are some examples of “red flags” that pharmacists are expected to recognize as potential signs of prescription drug misuse or diversion?
- How did CVS allegedly react to the implementation of an automated system that flagged high-risk prescriptions, according to the government’s complaint?
- What arguments does CVS use to defend itself against the lawsuit, and what actions has it taken in recent years related to opioid prescriptions?
- What does the case of Pronto Pharmacy, and the subsequent Supreme Court decision in Ruan v. United States, reveal about the challenges in prosecuting healthcare practitioners for opioid-related violations?
Answer Key
- The lawsuit alleges that CVS violated the Controlled Substances Act (CSA) by knowingly filling unlawful prescriptions for controlled substances and the False Claims Act (FCA) by seeking reimbursement from federal healthcare programs for those unlawful prescriptions.
- The complaint alleges that CVS implemented corporate policies, including performance metrics, incentive compensation, and inadequate staffing levels, that pressured pharmacists to fill prescriptions quickly without proper due diligence, prioritizing profits over patient safety.
- PDMPs are used by law enforcement to identify prescribers and patients with high volumes of controlled substance prescriptions, which can help identify potential diversion or “pill mills.” However, critics argue that this practice has led to a chilling effect on legitimate pain management, with practitioners becoming hesitant to prescribe opioids even for patients with genuine need.
- The CDC guidelines, while intended to be voluntary, have been adopted as rigid rules by many states and have been criticized for lacking a strong scientific basis, particularly the use of MMEs as a sole measure of risk. This has resulted in many patients with chronic pain being denied adequate opioid therapy.
- Algorithmic bias occurs when AI systems, due to flaws in their design or training data, produce outcomes that are systematically unfair to certain groups of people. This can lead to disparities in healthcare access, law enforcement targeting, and other areas.
- Dr. Lawhern argues that the term “opioid use disorder” is misleading because it conflates physical dependence, a natural consequence of prolonged opioid use, with addiction. He believes this has led to the overdiagnosis of addiction and the undertreatment of pain.
- Some red flags include excessive quantities of opioids, “doctor shopping” or “pharmacy shopping,” “trinity” prescriptions, early refills, cash payments, and long distances between the patient, prescriber, and pharmacy.
- When an automated system flagged a large number of potentially problematic prescriptions, CVS allegedly chose to weaken the alert system rather than address the underlying issue of high-risk prescribing, suggesting a prioritization of profit over safety.
- CVS argues that the lawsuit is a misguided attempt to extract more money from the company after it already settled with states over opioid litigation. It claims to have taken steps to fight opioid misuse, including refusing to fill prescriptions from certain prescribers.
- Pronto Pharmacy was raided by the DEA, but the case highlights the legal challenges in proving criminal negligence in opioid prescribing. The Supreme Court decision in Ruan v. United States clarified that the government must prove that a practitioner either subjectively knew a prescription was invalid or objectively acted outside the usual course of professional practice.
Essay Questions
- Evaluate the effectiveness of the U.S. government’s response to the opioid crisis, considering both its intended consequences and its unintended negative impacts. Discuss the ethical implications of using algorithms and data-driven approaches in healthcare and law enforcement.
- Analyze the arguments for and against the use of prescription drug monitoring programs (PDMPs). Consider the balance between preventing opioid misuse and ensuring access to appropriate pain management for patients with legitimate needs.
- Critically examine the role of the pharmaceutical industry, including companies like CVS, in the opioid crisis. To what extent are these corporations responsible for the widespread misuse of opioids, and what are their obligations to mitigate the harm caused?
- Discuss the concept of “pseudo-addiction” and its implications for the diagnosis and treatment of pain. How can healthcare providers differentiate between behaviors driven by untreated pain and those indicative of addiction?
- Explore the challenges of balancing the legitimate medical use of opioids with the risks of misuse and addiction. Propose solutions that address the needs of both patients with chronic pain and individuals struggling with opioid use disorder.
